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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biliary stent system for benign strictures
Regulation Description Metallic biliary stent system for benign strictures.
Definition A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.
Product CodePNB
Regulation Number 876.5011
Device Class 2

MDR Year MDR Reports MDR Events
2021 29 30
2022 16 16
2023 27 28
2024 39 40
2025 37 37
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 52 52
Migration 33 33
Break 30 30
Device Stenosis 28 29
Positioning Problem 28 28
Material Deformation 21 21
Use of Device Problem 13 14
Detachment of Device or Device Component 8 8
Material Integrity Problem 7 8
Adverse Event Without Identified Device or Use Problem 7 7
Obstruction of Flow 6 6
Premature Activation 6 6
Activation, Positioning or Separation Problem 5 5
Defective Device 5 5
Difficult or Delayed Positioning 5 5
Activation Failure 5 5
Human-Device Interface Problem 5 5
Failure to Advance 4 4
Device Markings/Labelling Problem 3 3
Difficult to Advance 3 3
Positioning Failure 3 3
Device-Device Incompatibility 2 2
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Entrapment of Device 1 1
Mechanical Problem 1 1
Output Problem 1 2
Material Puncture/Hole 1 1
Wrong Label 1 1
Unsealed Device Packaging 1 1
Unraveled Material 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 118 120
Hemorrhage/Bleeding 8 8
Insufficient Information 7 8
Inflammation 5 5
Jaundice 5 5
Liver Damage/Dysfunction 5 5
Fever 4 4
Abdominal Pain 3 3
Pain 3 3
Pancreatitis 3 3
Depression 2 2
Obstruction/Occlusion 2 2
Foreign Body In Patient 2 2
Peritonitis 2 2
Anxiety 2 2
Perforation 2 2
Failure of Implant 2 2
Fatigue 2 2
Pulmonary Embolism 1 1
Fistula 1 1
Anemia 1 1
Erosion 1 1
Emotional Changes 1 1
Unspecified Infection 1 1
Hypoxia 1 1
Pneumonia 1 1
Sepsis 1 1
Perforation of Vessels 1 1
Discomfort 1 1
Pressure Sores 1 1
Chills 1 1
No Consequences Or Impact To Patient 1 1
Itching Sensation 1 1
Thrombosis/Thrombus 1 1
Ascites 1 1
Restenosis 1 1

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